FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THORACOSCOPE/LAPAROSCOPE
K Number: K931954
·
Decision Nov 2, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
17
Applicant Total
28
Review Days
196
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Basic Information
- Device Name
- THORACOSCOPE/LAPAROSCOPE
- K Number
- K931954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Technologies, Inc.
- Date Received
- April 20, 1993
- Decision Date
- November 2, 1993
- Product Code
- GCM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCM | Endoscope, Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCM), ordered by most recent decision date.
TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSIDE VIEW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNISONIC ENDOSCOPIC DEFLECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941992 | CYSTOSCOPE | Nov 30, 1995 | Substantially Equivalent |
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |